Adenovirus CCL-21 Transduced MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured
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|ClinicalTrials.gov Identifier: NCT00798629|
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : September 24, 2012
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RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: Autologous dendritic cell-adenovirus CCL21 vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Ranging Trial of Adenovirus CCL-21 Transduced MART-1/gp100 Peptide-Pulsed Dendritic Cells Matured Using Cytokines for Patients With Chemotherapy-Resistant Metastatic Melanoma|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Experimental: Vaccine Dose Escalation
Dose Escalation: Intradermal DC Injection. Level 1: Cell Dose: 2 x 10^6 Level 2: Cell Dose: 1 x 10^7 Level 3: Cell Dose: 2 x 10^7
Biological: Autologous dendritic cell-adenovirus CCL21 vaccine
Intradermal injections of adenovirus-CCL-21 transduced class I peptide-pulsed DC
- Number of Participants with Immune response [ Time Frame: 2 years, 5 months ]Assessment of immune responses to the cytokine-cocktail-matured class I peptide-pulsed adenoviral CCL-21 transduced DC cell vaccine. Immune reactivity will be monitored for the appearance of lymphoid-like structures at the vaccine site (as a result of CCL-21 production), in the blood for MART-1 /gp100 specific T cell frequency by tetramer based flow cytometry and ELISPOT analysis of fresh cells, and CTL cytolytic reactivity after in vitro sensitization prior to, four weeks after, and 8 weeks after immunization.
- Number of Participants with Adverse Events [ Time Frame: 2 years, 5 months ]Toxicity as assessed by NCI CTCAE v3.0
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Metastatic melanoma with measurable disease after attempted curative surgical therapy and who have received at least one prior chemotherapy regimen; adjuvant interferon or isolated limb perfusion is allowed.
- Tumor tissue must be available for immunohistochemical analysis, and specimens will stained for MART-1 by immunohistochemical staining and will also be stained for HMB-45 by immunohistochemistry, and positivity for at least one will be an entry requirement.
- Patients must be HLA-A *0201 positive, by a DNA SSOP analysis.
- Serum creatinine of 2.0 mg/dl or less, total bilirubin of 2.0 mg/dl or less, and ALT/AST of less than 3X institutional upper limit of normal.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must be able to understand and sign an IRB approved informed consent form.
- Patients must have white blood count of 3000 or greater, platelets of 100,000 or greater, and hemoglobin of 9.0 gm/dl or more.
- Patients with unresectable stages III/IV uveal melanoma and metastatic mucosal melanoma will be eligible for this trial.
- Undergoing or have undergone in the past month any other therapy for their melanoma, including radiation therapy, chemotherapy and adjuvant therapy
- Have major systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems, or have had a documented MI in the last 6 months
- Require steroid therapy
- Patients who are pregnant or lactating
- Known to be positive for hepatitis BsAg, Hepatitis C or HIV antibody
- Have a prior history of uveitis or autoimmune inflammatory eye disease
- Have had another malignancy other than cervical carcinoma-in-situ or basal cell /squamous cancer of the skin, unless they have undergone curative therapy more than 3 years ago and are still free of detectable disease, since the effects of peptide-pulsed DC on other active cancers are unknown
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798629
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Jeffrey S. Weber, MD, PhD||H. Lee Moffitt Cancer Center and Research Institute|
|Responsible Party:||H. Lee Moffitt Cancer Center and Research Institute|
|Other Study ID Numbers:||
NCI P-8190 ( Other Grant/Funding Number: NCI )
|First Posted:||November 26, 2008 Key Record Dates|
|Last Update Posted:||September 24, 2012|
|Last Verified:||September 2012|
stage III melanoma
stage IV melanoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas